FDAClass IIJune 12, 2019

Pericardiocentesis Catheter Tray recall

Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284

Why was Pericardiocentesis Catheter Tray recalled?

Affected products may have been manufactured with the catheter distal end hole too small

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number NS7726043

Product
Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
Recalling firm
Cook Inc.
Quantity
2 kits
Distribution
Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Recall date
June 12, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls